Search Orphan Drug Designations and Approvals
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Generic Name: | terlipressin | ||||||||||||||||
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Trade Name: | Terlivaz | ||||||||||||||||
Date Designated: | 10/29/2004 | ||||||||||||||||
Orphan Designation: | Treatment of Hepatorenal Syndrome | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Mallinckrodt Pharmaceuticals Ireland Ltd College Business & Technology Park Cruiserath Road Blanchardstown, Dublin, Ireland D15 TX2V Ireland The sponsor address listed is the last reported by the sponsor to OOPD. |
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Marketing approved: |
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1 | Generic Name: | terlipressin |
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Trade Name: | Terlivaz | |
Marketing Approval Date: | 09/14/2022 | |
Approved Labeled Indication: | To improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function | |
Exclusivity End Date: | 09/14/2029 | |
Exclusivity Protected Indication* : | To improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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